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Normal Saline Versus Betadine Use to Reduce the Incidence of Wound Infection in Cesarean Section

Primary Purpose

Incidence of cs Scar Infection

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
irrigation
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Incidence of cs Scar Infection focused on measuring saline, betadine, cesarean scar infection

Eligibility Criteria

19 Years - 37 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects candidate for the study will be 37 weeks' gestation
  • require a cesarean section (elective or emergency).

Exclusion Criteria:

  • Patients with allergy to iodine
  • history of immunosuppressive drug use,
  • gestationaldiabetes mellitus
  • preeclampsia
  • anemic patients
  • ruptured of membranes
  • feverish patients

Sites / Locations

  • Kasr El Ainy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Placebo Comparator

Experimental

Arm Label

no irrigation group

saline irrigation group

betadine irrigation group

Arm Description

nothing used for irrigation of cs scar

saline used for irrigation the cs scar before closure

betadine used for irrigation of cs scar

Outcomes

Primary Outcome Measures

incidence of cs scar infection
incidence of cs scar infection

Secondary Outcome Measures

incidence of hematoma, seroma
incidence of hematoma, seroma, wound breakdown

Full Information

First Posted
October 20, 2018
Last Updated
October 29, 2018
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03725748
Brief Title
Normal Saline Versus Betadine Use to Reduce the Incidence of Wound Infection in Cesarean Section
Official Title
Normal Saline Versus Betadine Use to Reduce the Incidence of Wound Infection in Cesarean
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Anticipated)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective randomized controlled study to the difference between using normal saline or betadine irrigation of wound prior to skin closure in reducing the incidence of wound infection after Cesarean section.
Detailed Description
This study will be conducted at the Department of Obstetrics & Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, from February to July 2018. We include in our study 3oo pregnant women who will undergo Cesarean section. All participants will be divided into 3 groups with a 1:1:1 ratio with 100 patients in each group. Each participant will provide an informed written consent. Consenting patients will be pre-operatively randomised using numerically ordered cards in sealed envelopes to either the group 1 (wound irrigation with 100 ml of normal saline before skin closure) or the group 2 (wound irrigation with 50 ml of 10% aqueous povidone iodine solution ̋ Betadinȅ ) or the control group (no wound irrigation with normal saline nor betadine).Subjects candidate for the study will be 37 weeks' gestation and require a cesarean section (elective or emergency). Patients with allergy to iodine, history of immunosuppressive drug use, gestationaldiabetes mellitus or preeclampsia, anemic patients, ruptured of membranes and feverish patients will be excluded from the study. The primary outcome will be the incidence of wound infection. Wound infection is diagnosed when the wound drained purulent material or serosanguineous fluid in association with induration, warmth and tenderness. Suspected wound infections are opened for confirmation and wound cultures will be taken. Haematoma, seroma, or wound breakdown in the absence of the previouslydiscussed signs is not considered a wound infection.Wounds are examined twice daily during hospitalization for evidence of infection. After discharge, the women are instructed on the signs and symptoms of wound infection, and asked to contact one of the co-authors immediately if any of the listed symptoms appeared. All participants are examined at 2 and 6 weeks after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incidence of cs Scar Infection
Keywords
saline, betadine, cesarean scar infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
no irrigation group
Arm Type
No Intervention
Arm Description
nothing used for irrigation of cs scar
Arm Title
saline irrigation group
Arm Type
Placebo Comparator
Arm Description
saline used for irrigation the cs scar before closure
Arm Title
betadine irrigation group
Arm Type
Experimental
Arm Description
betadine used for irrigation of cs scar
Intervention Type
Other
Intervention Name(s)
irrigation
Intervention Description
irrigation the edges of the cs scar before closure
Primary Outcome Measure Information:
Title
incidence of cs scar infection
Description
incidence of cs scar infection
Time Frame
2 to 6 weeks
Secondary Outcome Measure Information:
Title
incidence of hematoma, seroma
Description
incidence of hematoma, seroma, wound breakdown
Time Frame
2 to 6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects candidate for the study will be 37 weeks' gestation require a cesarean section (elective or emergency). Exclusion Criteria: Patients with allergy to iodine history of immunosuppressive drug use, gestationaldiabetes mellitus preeclampsia anemic patients ruptured of membranes feverish patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hany saad, assistant prof
Phone
01001817211
Email
dr_hanysaad@yahoo.co.uk
First Name & Middle Initial & Last Name or Official Title & Degree
ashraf saad, lecturer
Phone
01001817221
Email
ashraf@yahoo.co.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fady salah, lecturer
Organizational Affiliation
Director
Official's Role
Study Director
Facility Information:
Facility Name
Kasr El Ainy
City
Cairo
ZIP/Postal Code
02
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed saad, lecturer
Phone
01244336666
Email
msaad@scimitar.com

12. IPD Sharing Statement

Learn more about this trial

Normal Saline Versus Betadine Use to Reduce the Incidence of Wound Infection in Cesarean Section

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